On Friday, April 7, two federal courts issued competing rulings on the viability of the abortion pill mifepristone. The first ruling was from Texas Judge Matthew Kaczmarek, a Trump appointee, sitting on the federal bench in Amarillo. He issued a preliminary injunction halting the approval by the Food and Drug Administration of mifepristone, the first-stage medical abortion pill. He cited as his reason the failure of the FDA to consider side effects of the drug, including what he characterized as post-traumatic stress that women may suffer after their medical abortions. The judge believed that approval by the FDA was rushed, despite over 20 years of safe and effective experience.
The ruling by Judge Kaczmarek will not go into immediate effect, giving the Biden administration the opportunity to appeal the ruling to the Fifth Circuit Court of Appeals. If the decision is affirmed, it will have nationwide effect, despite the fact that the United States Supreme Court decision in Dobbs v. Jackson Women’s Health left the decision about the legality of abortion to each state.
Just a few hours later, federal court Judge Thomas Rice, an Obama appointee, sitting in Spokane, Washington, ordered the FDA to preserve the status quo, maintaining access to the drug in the 17 states and the District of Columbia that brought the Washington case, and where abortion remains legal. The two cases are set on a collision course.
The majority of abortions in the United States are medical and not surgical. Here, medical abortions are implemented in two stages. The first stage is with mifepristone, the subject of the Friday rulings, and it terminates the pregnancy. The second stage is with misoprostol, a medication used to soften the cervix and prompt contractions, which will expel the embryo or fetus. Misoprostol is widely used alone to perform abortions in other countries, but studies have shown that it is not as effective as the two-step regimen, and causes more cramping and bleeding. Mifepristone was first cleared for use in the United States in 2000. The Texas case marks the first time a judge has suspended the FDA’s approval of a medication over objection by the FDA and the drug’s manufacturer.
UPDATE April 14, 2023: On Friday, April 14, United States Supreme Court Justice Samuel A. Alito, Jr. issued a temporary administrative stay of Judge Kacsmaryk’s ruling, ensuring that mifepristone would remain available while the Court considers whether to grant the Biden administration’s urgent request to preserve the FDA’s approval of the medication. The drug’s manufacturer, Danco Laboratories, also filed an emergency application, arguing that the Court should defer to the FDA’s scientific determination of the drug’s safety. The stay expires at midnight Wednesday, and Justice Alito has ordered the groups challenging the medication’s approval to file their brief by Tuesday, signaling that the Court is likely to issue a decision this Wednesday.
UPDATE April 21, 2023: On Friday, April 21, the Supreme Court issued a ruling protecting access to the widely used abortion drug Mifepristone by freezing lower-court rulings that placed restrictions on its usage. As a result, the FDA’s approval of the drug will remain in place pending decisions on the appeals, which could take months.